Last updated: 07/17/2024 15:21:02
A Continuation Trial for Subjects with Lupus who completed Protocol HGS1006-C1056 in the United States
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 in the United States
Trial description: This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with the indicated type of adverse event (AEs) and serious adverse event (SAEs)
Timeframe: Up to Week 440
AE rates by system organ class (SOC) during the study
Timeframe: Up Week 440
SAE rates by system organ class (SOC) during the study
Timeframe: Up to Week 440
Change from Baseline in activated partial thromboplastin time (APTT) and prothrombin time (PT) at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in erythrocytes at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in hematocrit at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in hemoglobin at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in albumin and protein at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in creatinine, urate and bilirubin at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in creatinine clearance at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in BUN/creatinine at the indicated time points
Timeframe: Up to Week 440
Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase at the indicated time points
Timeframe: Up to Week 432
Number of participants with the indicated immunogenic response
Timeframe: Up to Week 440
Systolic blood pressure and diastolic blood pressure at indicated time points.
Timeframe: Up to Week 432
Percentage of participants with at least 25% increase from baseline in creatinine at indicated time points.
Timeframe: Up to Week 440
Percentage of participants with at least 25% reduction from baseline in creatinine at indicated time points. Amongst Subjects with Abnormal (>124 umol/L) Creatinine at Baseline by Year Interval.
Timeframe: Up to Week 440
Secondary outcomes:
Number of participants with serum immunoglobulins below the lower limit of normal at indicated time points.
Timeframe: Up to Week 392
Percentage of participants achieving SRI Response at indicated time points
Timeframe: Up to Week 440
Observed anti-double stranded DNA levels at indicated time points.
Timeframe: Up to Week 432
Median percent change from Baseline in anti-double stranded DNA at indicated time points.
Timeframe: Up to Week 432
Observed complement C3 and C4 levels at indicated time points
Timeframe: Up to Week 440
Median percent change from Baseline in complement C3 and C4 levels at indicated time points
Timeframe: Up to Week 432
Percent of participants with daily prednisone dose reduction at indicated time points.
Timeframe: Up to Week 432
Percent of participants with >= 50% reduction in proteinuria at indicated time points.
Timeframe: Up to Week 432
Observed B-cell levels at indicated time points.
Timeframe: Up to Week 432
Median percent change from Baseline in B cell levels at indicated time points.
Timeframe: Up to Week 432
Percentage of participants with worsening in SLICC/ACR damage index at indicated time points
Timeframe: Up to Week 384
Change from Baseline in SF-36 healthy survey overall component scores at indicated time point
Timeframe: Up to Week 384
Change from Baseline in SF-36 Healthy Survey Overall Component Scores at indicated timepoints
Timeframe: Up to Week 384
Change from Baseline in FACIT-Fatigue scale total score at indicated time point
Timeframe: Up to Week 384
Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the MCID at indicated time points
Timeframe: Up to Week 384
Interventions:
Enrollment:
268
Primary completion date:
2015-26-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus: a continuation of the Phase 3 United States BLISS-76 trial . Arthritis Rheum. 2018;70(6):868-877
DOI: 10.1002/art.40439
PMID: https://www.ncbi.nlm.nih.gov/pubmed/29409143
Herbert Struemper, Milena Kurtinecz, Lisa Edwards, William Freimuth, David Roth, William Stohl.Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE.Lupus Sci Med.2022;9(1):e000499
DOI: 10.1136/lupus-2021-000499
PMID: 35131846
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GSK
Study date(s)
August 2008 to March 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
- Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.
- Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
Inclusion and exclusion criteria
Inclusion criteria:
- Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
- Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.
Exclusion criteria:
- Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
Trial location(s)
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5542
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30303
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21205
Status
Study Complete
Showing 1 - 6 of 51 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-26-03
Actual study completion date
2015-26-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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